Kornimate/medical-research-clean huggingface dataset:
the effects of sensory stimulative activities on sleep performance in elderly adults: a single-case design

Conditions: Sleep Disturbance

Summary: older adults have a high prevalence of sleep disturbances, which negatively and severely impact their health and quality of life. research indicated that 43% elderly outpatients in taiwan have used benzodiazepine, which collectively led to great medical expenditure. non-pharmacological treatments are highly recommended as first priority for sleep disturbance in practice. music interventions have been reported to modulate the sympathetic nervous system and to improve the elderly's sleeping performance. proprioceptive interventions can also activate the parasympathetic nervous system, providing calming effects and significantly reducing anxiety, hyperactivity and agitation in various populations. however, the effects of these intervention on the sleep disturbances in the elderly remain unclear. the research purpose is to investigate the effects of two sensory activities that are easily executed in everyday life - auditory (e.g. listening to the music before sleeping) and proprioceptive (e.g. joint compression exercises) interventions on improving the sleep performance of the elderly. subjective sleeping quality assessment (pittsburgh sleep quality index \& insomnia severity index) and objective physiological records measured by actigraphy are used as outcome measures.

in this single-case designs study, we will recruit six volunteering elderly with primary insomnia and use a-b-a-c-a-d design for 9 weeks including the three periods of baseline phases for 1 week(a), the music intervention phase for 2 weeks(b), the proprioceptive intervention phase for 2 weeks(c) and the combination phase for 2 weeks(d). the main outcome measures include the objective sleeping quality measured everyday by the actigraphy recording the sleeping performance and physiological data during sleep, and the subjective sleeping quality measured every week via the pittsburgh sleep quality index and the insomnia severity. the secondary outcome measures, including the center for epidemiologic studies depression scale, geriatric anxiety scale - chinese version and whoqol-bref, will be assessed weekly. the above results will present in visually analyzing graphed data to compare the performance among different phases and to evaluate the impacts of different interventions. this study will aim to preliminary investigate the feasibility and effectiveness of the music intervention, the proprioception intervention and the combination of both approaches on improving the objective sleeping performance and the subjective sleeping quality of the elderly.

Eligibility criteria:
inclusion criteria: 1. have experienced insomnia (psqi\>5 at screening;) for at least one month. 2. over 65 years of age or older. exclusion criteria: 1. psychiatric or neurological problems 2. a history of alcohol / drug abuse 3. hearing impaired.
safety,tolerability and pharmacokinetics of multiple ascending doses of vch 916 in subjects with chronic hep c infection

Conditions: HCV Infection

Summary: the purpose of this study is to determine whether a 3-day course of therapy with orally administered vch-916 given at different dosages can effectively reduce the amount of circulating virus (i.e., viral load) in patients with early-stage chronic hepatitis c-infection. this study will also evaluate the safety and tolerability of treatment with vch-916. blood samples will also be taken to measure the levels of vch-916 present in plasma at various time points during the treatment period.


Eligibility criteria:
inclusion criteria: * males and females 18 to 60 years of age * no evidence of cirrhosis or have liver fibrosis corresponding to metavir stages 0 to 3 * subject's liver disease is stable with alt values \< 5 x uln * serologic evidence of detectable plasma hcv-rna of ≥ 100,000 iu/ml at screening * documented hcv genotype 1 chronic hepatitis c. * judged to be in good health on the basis of medical history and physical examination * all other hematology and clinical chemistry must be within normal limits or show no clinically significant abnormalities. * be treatment-naïve or experienced. * for female subjects, must not be pregnant or breastfeeding and must be postmenopausal, surgically sterile, abstinent, or using two proven methods of birth control. * sexually active male subjects, must be practicing acceptable methods of contraception during the treatment period * female subjects of childbearing potential must have a negative serum ß-hcg pregnancy test at screening and a negative urine pregnancy test on day 1 before the first dose of study drugs. * agree not to participate in other clinical trials for the duration of his/her participation in this clinical trial. exclusion criteria: * be participating in any other clinical studies or have participated in another clinical trial within the last 30 days before study drug administration, or participation in more than 2 drug studies in the last 12 months (exclusive of the current study). * be actively taking hard illicit drugs within 12 months prior to the screening visit or alcohol. * have a child-pugh score \> than 5. * have evidence of liver cirrhosis including histological evidence of hepatic cirrhosis on any liver biopsy. * have any cause of liver disease other than chronic hepatitis c-infection * active or malignant disease or suspicion or history of malignant disease within five previous years (except for adequately treated basal cell carcinoma). * have clinically significant electrocardiogram abnormalities and/or cardiovascular dysfunction within the previous 6 months * have significant renal, pulmonary, gastrointestinal absorption, or neurological diseases, or neoplasia. * have a history of psychiatric disorders determined by the investigator to contraindicate therapy. * have uncontrolled type 1 or type ii diabetes. * antinuclear antibody titer ≥1:320. * coinfection with hepatitis b and/or hiv 1 or hiv 2.
serum adiponectin as an early marker for renal impairment in patients with non-alcoholic fatty liver disease.

Conditions: Non-Alcoholic Fatty Liver Disease

Summary: early detection of renal impairment in patients with non-alcoholic fatty liver disease and its correlation with serum adiponectin level.

detection of serum adiponectin by elisa technique using (eia-3418) kit, drg international inc., usa

Eligibility criteria:
inclusion criteria: * patients with fatty liver aged from 18 to 60 yrs either diabetic or not . * patient with normal echogenic kidney in ultrasound and egfr more than 60 ml/min/1.73m2. * the control group are completely healthy subjects without any systemic or liver and kidney affection exclusion criteria: * patients less than 18 yrs \& more than 60 yrs . * all patients having any other causes of renal and hepatic disease rather than diabetes and having any other systemic problem.
social support and myocardial ischemia

Conditions: Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Coronary Disease

Summary: to examine the role of social support in attenuating ischemic responses to psychological stress, both in the laboratory and during daily life.

background: a large quantity of epidemiological data has accumulated attesting to a link between social support and the progression of cardiovascular disease in cardiac patients. one way that social support might exerts its health effects is by attenuating physiological responses to psychological stress, since these responses have been related to cardiovascular disease. much myocardial ischemia occurring during daily life appears to be related to periods of psychological stress, and laboratory mental stress tasks have been found to induce ischemia. thus, the incidence, severity, and duration of myocardial ischemia might be modified by changes in the social environment. design narrative: there are two components to the study. in the first component, the investigators are testing the hypothesis that the presence of a supportive spouse attenuates ischemic responses to psychological stress in the laboratory. using a counterbalanced crossover, repeated measures design, patients are asked to complete a public speaking task in the laboratory in two conditions: with a spouse present; and alone. hemodynamic, radionuclide angiographic, and catecholamine responses to the task are assessed in both conditions. in the second component, the investigators are examining whether married patients show reduced duration of ischemia compared to unmarried patients. in addition, they plan to examine whether presence of a supportive other (spouse, or friend in the case of unmarried patients) reduces the incidence and duration of ischemia in patients during daily life activities. patients are asked to keep a detailed diary for a two week period to ascertain patterns of daily activities. using these diaries and in consultation with patients, the investigators are selecting a two day period during which patients have a busy and varied schedule. patients are then asked to follow the same pattern of activities for a 48 hour period on two consecutive weeks when heart rate, and the incidence and duration of ischemia are measured. during one week their spouse, in the case of married patients, or friend, in the case of unmarried patients, is present; during the other week patients are to repeat the activities alone.

Eligibility criteria:
no eligibility criteria
pharmacokinetic, pharmacodynamic and pharmacogenetic of morphine after surgery

Conditions: Orthopaedic Surgery

Summary: the main objective of this study is to improve our knowledge on the pharmacodynamic, pharmacokinetic, and pharmacogenetic relationships of morphine administered to relief severe postoperative pain. the analysis will encompass the efficacy (acute during titration and subacute during the first 24 hours) and adverse effects of morphine. our purpose is also to better characterize the age- and sex-related differences which probably markedly differ between the two periods (acute vs sub acute).

no previous study attempted to characterize the pharmacodynamic, pharmacokinetic, and pharmacogenetic relationships of morphine in the early postoperative period, whereas it is the main clinical situation for severe pain and a unique model for its study (not possible in the healthy volunteer). indeed, intravenous titration of morphine is the first step for pain control in the postanesthesia care unit. administration of intravenous boluses of morphine enables to obtain complete pain relief in 98% of the patients. we intend to study the effects of morphine (intravenous titration then patient-controlled intravenous administration (pca) for 24 hours), perform dosages of plasma concentration of morphine an its main metabolites, and also study gene polymorphisms coding for main proteins involved in the pharmacokinetic and pharmacodynamic profile of morphine (hepatic metabolism, distribution and elimination, interaction with morphine receptor). five hundred patients scheduled for major orthopedic surgery will be included in this prospective study. the main objective of this study is to improve our knowledge on the pharmacodynamic, pharmacokinetic, and pharmacogenetic relationships of morphine administered to relief severe postoperative pain. the analysis will encompass the efficacy (acute during titration and subacute during the first 24 hours) and adverse effects of morphine. our purpose is also to better characterize the age- and sex-related differences which probably markedly differ between the two periods (acute vs subacute). we consider that this knowledge is important to confirm or not several important concepts currently used to define the appropriate analgesic regimen to control severe pain in the postoperative period.

Eligibility criteria:
inclusion criteria : * scheduled major orthopedic surgery * spine, hip or knee surgery * body weight between 50 and 100 kg * caucasians * asa status 1 to 3 * no cognitive dysfunction exclusion criteria : * allergy or contraindication to morphine * renal impairment (cr cl \< 30 ml/min) * severe hepatic impairment * surgery performed under regional anaesthesia * preoperative treatment including strong or weak opioids * pregnancy, patients under 18 years, addiction

Keywords: morphine titration sub acute pain major orthopaedic surgery pharmacokinetics pharmacodynamics genetic polymorphism pacu patients undergoing major scheduled orthopaedic surgery
soluble ve-cadherin and ve-cadherin antibody in sclerodermic sclerosis

Conditions: Primary Raynaud Disease; Systemic Sclerosis

Summary: ve-cadherin is expressed in endothelial cells. systemic slerosis is a rare auto-immune disease with a endothelial dysfunction. this study is to evaluated the level of soluble ve-cadherin and ve-cadherin antibody in patients with systemic slerosis.


Eligibility criteria:
inclusion criteria: * group 1: systemic sclerosis * group 2: raynaud primary disease

Keywords: soluble ve-cadherin antibody systemic slerosis
assessing performance of the testing done simple covid 19 antigen test

Conditions: COVID-19

Summary: this study will measure the sensitivity and specificity of the testing done simple severe acute respiratory syndrome (sars) cov-2 antigen test in subjects with suspected covid-19 that present throughout several urgent care clinics. the antigen test performance will be compared to a real-time polymerase chain reaction (rt-pcr) test.

the testing done simple antigen test is a lateral flow immunoassay that detects the presence of the sars cov-2 nucleoprotein and is primarily intended for use in an at home setting. the antigen test will be compared to a traditional rt-pcr tested nasal swab specimens. the purpose of study is to measure the performance of the testing done simple test via sensitivity and specificity when compared to the gold-standard rt-pcr test. the test will be administered in symptomatic and asymptomatic subjects and participants will report the days that has passed since their symptom onset. the rt-pcr test will be performed prior to the testing done simple test.

Eligibility criteria:
inclusion criteria: * subject was given a sars cov 2 pcr test for any of the following 4 reasons: 1. subject has covid like symptoms that started within past (7) days 2. subject has been exposed to another individual with a known covid diagnosis or probable covid diagnosis 3. subject needs covid test done for travel, school, work, etc 4. subject works in a high risk environment * subject can provide a nasal swab sample * subject is at least 18 years of age * subject was given a sars cov 2 pcr test on same day participating this study * subject provides informed consent exclusion criteria: * subject is less than 18 years of age * subject does not provide consent * subject's covid 19 related symptom(s) started greater than 7 days from visit * asymptomatic subjects whom have had symptom(s) within past (14) days * signs of local infection in the area of the face * subject was not given a sars cov 2 pcr test on same day as study

Keywords: antigen test test diagnosis
a study to assess change in disease state in adult participants with acute myeloid leukemia (aml) receiving oral venetoclax tablets in combination with subcutaneously (sc) or intravenously (iv) injected azacitidine in colombia

Conditions: Acute Myeloid Leukemia

Summary: acute myeloid leukemia (aml) is a cancer of the blood and bone marrow and is the most common acute leukemia in adults. this study will evaluate how well venetoclax in combination with azacitidine works to treat aml in adult participants in colombia. venetoclax in combination with azacytidine is approved to treat acute myeloid leukemia (aml). all study participants will receive venetoclax in combination with azacitidine as prescribed by their study doctor in accordance with approved local label. adult participants with a new diagnosis of aml will be enrolled. around 70 participants will be enrolled in the study in colombia. participants will receive venetoclax tablets to be taken by mouth in combination with azacitidine given by subcutaneous (sc) or intravenous (iv) injection according to the approved local label. the duration of the study is approximately 36 months. there is expected to be no additional burden for participants in this trial. all study visits will occur during routine clinical practice.


Eligibility criteria:
inclusion criteria: * newly diagnosed acute myeloid leukemia (aml) defined as participants that have histological confirmation of aml (de novo, secondary) by world health organization (who) criteria, and have not received any prior treatment for aml. * ineligible to intensive chemotherapy due to \>=75 years of age; or \>=18 to 74 years who have comorbidities that preclude use of intensive induction chemotherapy. * participants starting treatment with venetoclax in combination with azacytidine treated according to the colombia label and who are not completed the first cycle (cycle 28 days). exclusion criteria: - participating in an interventional clinical trial within 30 days prior to venetoclax treatment initiation.

Keywords: acute myeloid leukemia venetoclax venclexta venclyxto azacitidine abt-199 cancer
radiation pneumonitis after sbrt for nsclc

Conditions: Lung Cancer; Radiotherapy; Lung Function Changes

Summary: aims: 1. evaluate changes in lung function before and after radiotherapy for patients with nsclc in stage i-iii receiving curatively intended radiotherapy 2. to assess the predictive value of pulmonary function tests for the development of radiation pneumonitis after curative radiotherapy 3. to assess biomarkers in blood samples before, during, and after radiotherapy and correlate to the development of radiation pneumonitis 4. investigate survival

this prospective longitudinal study planned to include 70 patients with nsclc in stages i-iii who will be its own control group for changes in lung function. it will be included patients destined to have stereotactic or concomitant chemoradiotherapy in curative intent. follow-up will include a physical examination by a pulmonologist, spirometry, determination of the diffusion capacity for carbon monoxide (dlco), determination of the total lung capacity (tlc), residual volume (rv) and intrathoracic gas volume (itgv) by body plethysmography, determination of the partial pressure of carbon dioxide (paco2) and oxygen (pao2) by arterial blood gas analysis, the six-minute walking test, the clinical copd questionnaire, x-ray and ct scans and blood sample analysis at baseline, 4 to 6 weeks after treatment, and every 3 months thereafter until 12 months after sbrt. part of the project is to take blood samples. specific blood samples will be analyzed to identify biomarkers that could predict the development of radiation-induced lung changes. unfortunately, fewer patients than planned were included.

Eligibility criteria:
inclusion criteria: * age \> 18 years old * current lung cancer, not older than 8 weeks * received written consent * non small cell lung cancer * stage ia-iiia * inoperable exclusion criteria: * lack of consent * operable * additional cancer disease * small cell lung carcinoma or neuroendocrine lung cancer
prevalence of covid-19 in high altitude : insights from the highest city of the world

Conditions: Covid19; High Altitude

Summary: since the beginning of 2020, sars-cov-2 outbreak spread over the world, conducting in a pandemic state declared by the world health organization in march 2020. conflicting data have been yet published regarding to the incidence rate of covid-19 infection in altitude. mainly based on analysis from national peru database, some authors argued that covid-19 disease, as well as case fatality rate was less frequent in altitude. however, epidemiological data are lacking regarding to the prevalence of covid-19 in altitude, and more specially in high altitude. aim of this cross-sectional study is to assess the prevalence of seroconversion for the sars-cov-2 in the population of la rinconada, a mining town at 5,100 m, the highest city in the world.


Eligibility criteria:
inclusion criteria: - age \> 18 years. exclusion criteria: * age \< 18 years. * inability to give informed consent.

Keywords: prevalence covid-19 sars-cov-2 hight altitude
clinical implementation of surface-guided radiation therapy in vulvar cancer

Conditions: Vulvar Cancer

Summary: this prospective study evaluated the clinical implementation value of an optical surface monitoring system (osms) in the radiotherapy setup for patients with vulvar cancer, compared to standard laser-based setup

this was a prospective single-centre trial to investigate the value of osms, and we hypothesized that using osms would reduce setup error in vulvar cancer treatment compared to a standard laser-based setup. a dose of 45 gy was delivered to the clinical target volume with intensity-modulated radiation therapy (imrt) for a total of 25 fractions, followed by 16 to 24 gy of local electron beam supplementation. marks were placed on each patient's skin to align the room lasers for presetup, and the setup was completed with information from the osms. the deviation values in three translation directions, lateral (lat), longitudinal (lng), and vertical (vrt), and three rotation directions, rtn (rotation along the z-axis), pitch (rotation along the x-axis), and roll (rotation along the y-axis) were obtained. the absolute values of setup error and error distribution of the standard laser-based setup and osms were compared.

Eligibility criteria:
inclusion criteria: 1. patients must be informed of the investigational nature of this study and give written informed consent before treatment. 2. age ≥18 years and ≤ 85 years. 3. patients with histologically confirmed vulvar cancer. 4. no evidence of distant metastasis on ct, mri or positron emission tomograph (pet)/ct. 5. no contraindications to ct scanning. 6. indications for radiotherapy for vulvar cancer. 7. adequate marrow: neutrophile granulocyte count ≥1.5\*10\^9/l, hemoglobin ≥ 80 g/l, platelet count ≥100\*10\^9/l. 8. normal liver and kidney function: creatinine (cr) \< 1.5 mg/dl, alanine aminotransferase (alt), aspartate aminotransferase (ast) \< 2\*upper limit of normal (uln). exclusion criteria: 1. no pathological diagnosis. 2. remote metastasis. 3. anticipated intolerance of pelvic radiotherapy. 4. any severe disease which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control, and emotional disturbance.

Keywords: vulvar cancer setup error intensity-modulated radiation therapy optical surface monitoring system